Status:
COMPLETED
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
Lead Sponsor:
Eximis Surgical
Collaborating Sponsors:
Proxima CRO
Conditions:
Laparoscopic Gynecological Surgical Procedures
Eligibility:
FEMALE
21-49 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
Detailed Description
This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women u...
Eligibility Criteria
Inclusion
- Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6 cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second longest dimension, based on preoperative assessment.
- Pre-operative evaluation, which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.
- Signed informed consent. Willing to adhere to protocol requirements and complete follow-up.
Exclusion
- Subject is post-menopausal, defined as amenorrhea \>12 months in the absence of ovulation suppression.
- Known or suspected malignancy of gynecological origin as determined by standard clinical practice.
- Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.
- Hemoglobin \< 8 g/dl within 30 days prior to surgery. Subject has a current history of undiagnosed genital bleeding Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).
- Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.
- Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.
- Concurrent participation in another therapeutic or interventional clinical trial with investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation of this study as determined by the Investigator.
- Inability to comply with the study procedures or follow-up in the opinion of the investigator.
- Subject is pregnant.
- Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site exceeds 6 cm.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06572163
Start Date
September 20 2024
End Date
October 25 2025
Last Update
October 30 2025
Active Locations (4)
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1
Advent Health, 410 Celebration Place
Celebration, Florida, United States, 34747
2
Rosemark Womens Care Specialists
Idaho Falls, Idaho, United States, 83404
3
Maimonides Medical Center
Brooklyn, New York, United States, 11219
4
Oregon Health and Science University School of Medicine
Portland, Oregon, United States, 97239